Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.41 (Draize test)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-hydroxyethanesulphonate
EC Number:
213-037-4
EC Name:
Sodium 1-hydroxyethanesulphonate
Cas Number:
918-04-7
Molecular formula:
C2H6O4S.Na
IUPAC Name:
sodium 1-hydroxyethane-1-sulfonate
Details on test material:
Name of the test substance used in the study report: Acetaldehydbisulfit spezial = 1-Hydroxy-1-ethyl-natriumsulfonat

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
Acclimatization period: ca. 8 days before study start
Mean body weight: males 2.74 kg, females 2.82 kg
Singly housing in stainless steel wire mesh cages (area: 40 x 51 cm).
The animals were identified via ear tattoo.
Room temperature: 20 -26°C
Relative humidity: 50 - 80%
Day/night rhythm: 12 h light and 12 h darkness
The animals were offered a standard animal laboratory diet (about 130 g/animal/day) and tap water (about 250 ml/animal/day).

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
about 0.5 g of a 50% aqueous solution
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
Clipping of the fur: at least 15 hours before application
Application area: 2.5 x 2.5 cm (intact and abraded skin in each case)
Application site: upper third of the back
The test substance was not washed off.
Scoring according to J.H. Draize, 1959
Readings: 15 - 30 minutes after removal of the test patches as well as 48 h, 82 h and 8 day after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: application on intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
other: application on intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: application on intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
other: application on intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 8 days
Score:
0
Max. score:
0
Remarks on result:
other: application on intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 8 days
Score:
0
Max. score:
0
Remarks on result:
other: application on intact skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met